Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: remimazolam group, dexmedetomidine group, esketamine group.
- Who it may be relevant to
- Registry conditions: Remimazolam, Dexmedetomidine, Esketamine. Basic parameters: 2 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study of the Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
Overview
By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.
Detailed description
Participants will be randomly allocated to three groups: remimazolam group(Group A), dexmedetomidine group(Group B), esketamine group(Group C). Before entering the operating room, an intravenous access is established. Under the accompaniment of a parent, one of the three drugs is administered intravenously.
Interventions
- Drug remimazolam group
remimazolam is administered intravenously at a dose of 0.3 mg/kg - Drug dexmedetomidine group
dexmedetomidine is administered intravenously at a dose of 1 μg/kg - Drug esketamine group
esketamine is administered intravenously at a dose of 0.5 mg/kg
Primary outcome measures
- Sedation success rate [Time frame: 0, 3, 5, 10 minutes after the drug injection]
- Onset time of sedation [Time frame: 0, 3, 5, 10 minutes after the drug injection]
- Parent-Child Separation Anxiety Score (PASA Score) [Time frame: 0, 3, 5, 10 minute after the drug injection]
Secondary outcome measures (7)
- Mask Acceptance Score (MAS) [Time frame: 0, 3, 5, 10 minutes after the drug injection]
- incidence of adverse reactions [Time frame: during intravenous bolus administration of sedative drugs and anesthesia induction]
- restlessness rating scale for awakening period(PAED) [Time frame: 0, 5, 10, 20 minutes after the patient awake]
- Heart rate [Time frame: 0, 3, 5, and 10 minutes after the drug injection]
- blood pressure [Time frame: 0,3,5,10 minute after drug injectuion]
- respiratory rate [Time frame: 0,3,5,10 minute after drug injectuion]
- pulse oximetry saturation [Time frame: 0,3,5,10 minute after drug injectuion]
Eligibility criteria
Inclusion criteria
- Children aged 2 to 5 years old
- the American Society of Anesthesiologists (ASA) physical status of Class I
- scheduled for adenotonsillectomy under general anesthesia, will be included.
Exclusion criteria
- Abnormal lung function and respiratory system function
- airway obstruction or deformity, history of mental illness
- electrocardiogram indicating bradycardia
- history of cardiac disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Maternal and Child Health Hospital of Hubei Province — Wuhan
Identifiers
NCT: NCT07050212 · MCHH_013